Breakthrough for the generation of fully functional skin tissue and other tissues will follow

PolarityTE™, Inc. (NASDAQ: COOL) today announced pre-clinical results demonstrating that the Company’s lead product, SkinTE™, regenerated full-thickness, organized skin and hair follicles in third degree burn wounds. The findings represent the first known successful regeneration of skin and hair in full-thickness swine wound models, the standard animal model for human skin. The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017.

In pre-clinical models of full-thickness burns and wounds, SkinTE™ demonstrated scar-less healing, hair follicle growth, immediate complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers (www.polarityte.com/products/skinte). The SkinTE™ product, which utilizes the subject’s own skin, is prepared and used to treat the wound in less than 24 hours.

* A regenerative medicine company with a revolutionary proprietary platform technology developing products to regenerate fully functional tissue across a wide spectrum of tissues – skin, bone, muscle, cartilage, nerve, liver, and more
* The proprietary platform technology provides a springboard for repeated product development targeting independent multibillion dollar markets – wounds, bone (trauma, spinal fusion, craniofacial, dental), osteoarthritis, etc.
* A paradigm shift in tissue engineering concepts, utilizing autologous tissue with its stem cell niche and supportive cellular elements for immediate redeployment to the patient, taking advantage of the human bioreactor – an approach never taken before despite sound and simple principles with true regeneration of functional tissue as the goal
* Near-term major milestones include SkinTETM clinical application Q3 2017 and market entry 1H 2018, OsteoTM clinical application Q2 2018 and market entry Q4 2018, and numerous products following in parallel
* Tissue regeneration is a prime focus for the government, specifically military and disaster applications, providing numerous prospects for large grants and contracts
* The leaders of the company have extensive clinical and surgical experience, with a strong backing of leading physicians across numerous specialties, allowing for targeted product development and streamlined clinical roll-out
* Most importantly, PolarityTETM truly provides a platform for continuous growth, with every corner of the $57B regenerative medicine market available for disruption

“These findings using SkinTE™ demonstrate an entirely new and pragmatic system whereby Polarity has used autologous tissue to regenerate full-thickness skin, hair follicles and appendages for the treatment of burns and wounds. This is a first for regenerative medicine and validation of the Polarity regenerative tissue platforms in pre-clinical studies across a variety of species,” said Denver M. Lough, M.D., Ph.D., Chairman and Chief Executive Officer of PolarityTE™. “We look forward to putting the SkinTE™ construct on human patients this year and releasing more data on our unique Polarity platform technology and pipeline of patient-specific constructs such as OsteoTE™ and CartTE™ shortly.”

Swine models of burns and wounds are known to be predictive of results found in humans due to the unique similarities between swine and human skin. Of note, it is believed that swine skin may be more difficult to regenerate with all layers and appendages (hair and glands), as was done in the studies by PolarityTE™, suggesting that the results of these studies may predict similar efficacy in human patients when clinical trials begin later this year.

“Our revolutionary approach to a new form of regenerative healing offers hope to both burn and wound patients, as well as medical providers who have not seen a significant advance in skin regeneration since the 1980s,” said Professor Stephen Milner, MD, DDS, DSc, FRCS(Ed), FACS, Chief Clinical Officer of PolarityTE and prior Director of the Johns Hopkins Burn Centers. “The efficacy and utility of current approaches to burn and wound care are currently severely limited, and leave a lasting effect on patients who suffer with scarring, disfigurement or even death. I believe that this astonishing physician-led team and unique technology platform, which uses the patient’s own tissues, has the potential to revolutionize regenerative medicine and be the foundation for a new paradigm of treatment and outcomes.”